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ready Medical Dictionary for Regulatory Activities Terminology

Abbreviation: MedDRA

General Information
MedDRA is a multilingual terminology allowing most users to operate in their native languages. MedDRA can be used to analyse individual medical events (e.g., “Influenza”) or issues involving a system, organ or etiology (e.g., infections) using its hierarchical structure. MedDRA can be used for signal detection and monitoring of clinical syndromes whose symptoms encompass numerous systems or organs using its multi-axial hierarchy or through the special feature of Standardised MedDRA Queries. The ability to communicate adverse event data is another strength of MedDRA and has lead to MedDRA being an integral part of the ICH e-submission standards: eCTD (ICH M8) and ICSRs (ICH E2B).

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Countries that developed this resource United States

Created in 1993

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How to cite this record MedDRA; Medical Dictionary for Regulatory Activities Terminology; DOI:; Last edited: June 27, 2019, 2 p.m.; Last accessed: Jan 17 2022 3:38 a.m.

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Record updated: June 27, 2019, 2 p.m. by The FAIRsharing Team.

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The use of a medical dictionary for regulatory activities terminology (MedDRA) in prescription-event monitoring in Japan (J-PEM).

Yokotsuka M,Aoyama M,Kubota K
Int J Med Inform 2000

View Paper (PubMed)

The medical dictionary for regulatory activities (MedDRA).

Brown EG,Wood L,Wood S
Drug Saf 1999

View Paper (PubMed) View Publication

MEDDRA Ontology Display

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